JP2023514939A - A system including an access device for the heart, a removable hemostatic valve unit, and a cardiac assist unit - Google Patents

Abstract

A system is disclosed that includes an access device for a heart chamber, a removable hemostatic valve unit, and a cardiac assist unit. In some examples, the access device (1) comprises an apical baseplate (100) and a wet zone from the heart chamber and a dry zone outside said heart chamber and within the patient and having a gaseous environment. It includes a sealing unit (3) configured to provide separation at the same time.
[Selection drawing] Fig. 11C

Description

The present disclosure relates generally to the field of cardiac medical devices. More particularly, the present disclosure relates to access devices for the heart, particularly transapical access devices that are transapical ports to and from the heart chambers. The present disclosure also relates to a hemostasis valve unit, particularly for delivering a medical device to the heart via the apex of the heart, and more particularly to a hemostasis valve unit having a variable orifice and preferably removable from the heart after use. and related to the hemostatic valve unit. Additionally, the present disclosure relates to medical procedures, methods, and systems for creating and therefore transapical passages in a beating heart. Additionally, the present disclosure relates to a medical system that includes a transapically implanted cardiac assist unit. Still further, the present disclosure relates to an apical baseplate including a connection interface. Additionally, the present disclosure relates to medical procedures, methods, and systems for and for transapically implanting cardiac assist systems.

This section is intended to introduce the reader to various aspects of art, which may be related to various aspects of the present disclosure, which are described and/or claimed below. This discussion is believed to be useful in providing the reader with background information to facilitate a better understanding of the various aspects of the present disclosure. It should therefore be understood that these statements are to be read in this light and not as an admission of prior art.

International Patent Publication No. WO2009100198A2 provides a transapical cardiac port, a method for making a transapical cardiac port, and a method for using a transapical cardiac port. However, these cardiac ports can be further improved.

British Patent No. GB1514019 discloses a hemostasis valve with a hydraulically controllable crossover. However, these hemostasis valves can be further improved.

International Patent Publication WO2018/167059A1 discloses a transapical cardiac port. The cardiac port is used during cardiac surgery to access the interior of the heart via the apex. After surgery is performed, the cardiac port is removed (page 8, lines 9-10). During surgery, said heart port is fitted with a hemostasis valve in its own housing, more precisely screwed onto the proximal part of the port. The valve is not disclosed as removable during use. The valve cannot be removed, ie disassembled from the port during use, as this could cause unwanted blood loss. The port is also disclosed as being removed from the patient and permanently implanted (i.e., the surgical procedure is completed and the patient's body is closed again) then within the patient's dry zone ( It is not disclosed as providing a dry zone.

International Patent Publication WO2011/017440A1 discloses an organ port, such as a transapical cardiac port, and methods and materials for implanting such an organ port. Ports are used during medical surgery and may include a hemostasis valve attached to the housing of such port and, for example, to reduce blood loss from the heart through the channel. be located. However, such ports are not disclosed as providing a dry zone in the patient when permanently implanted (i.e., when the surgery is over and the patient's body is closed again). .

US Patent Application Publication US2016/0081715A1 discloses a surgical access device for the introduction of surgical instruments into the body of a patient. The device includes a laterally moving seal cooperating with a bellows. A bellows is positioned between the inside and outside of the seal housing and establishes a biasing relationship with the seal. The device is not adapted for permanent implantation, eg, for use with cardiac assist devices. Also, it is not adapted as a transapical cardiac port for the heart.

A sealing assembly similar to a bellows is disclosed in US Pat. No. 5,492,304. The bellows allows reduction of the overall axial dimension of the sealing assembly. However, the device is not adapted for permanent implantation, eg, for use with cardiac assist devices. Also, it is not adapted as a transapical cardiac port for the heart.

For example, it would be desirable to simultaneously provide a permanent separation of a wet zone from a heart chamber and a dry zone having a gaseous environment outside said heart chamber.

Transapical access to prevent blood leakage while working on a beating heart and to allow attachment of units other than hemostatic valves, in particular other units having dimensions larger than the opening of the through-channel of the hemostatic valve. A device is desired.

It is also desirable to be able to transmit motion longitudinally across the apex of the heart without bleeding and to facilitate placement of a sealing unit at the apex.

Another desired property is that access to the heart chamber at a later time is facilitated, for example, for repair or replacement of components located inside the heart.

Embodiments of the present disclosure overcome one or more deficiencies in the art as set forth above by providing devices, systems and methods according to the appended claims, singly or in any combination. preferably seek to reduce, alleviate or eliminate any , disadvantage or problem.

The invention is defined solely by the appended claims, and in particular by the scope of the appended independent claims. Throughout the description, references to "embodiments" that do not fall within the scope of the appended claims merely represent possible exemplary implementations and are therefore not part of the invention.

According to aspects of the present disclosure, access devices for the heart, removable hemostatic valve units, systems and methods for creating a transapical passageway in a beating heart, and methods for transapically implanting a cardiac assist system are provided, Provided herein are medical systems that include a transapically implanted cardiac assist unit and an apical baseplate. An apical baseplate is a plate for attachment to the apical region of the heart.

As mentioned above, this document relates to medical devices. For example, this document provides trans-apical cardiac ports and methods for using trans-apical cardiac ports. The transapical cardiac ports provided herein can be inserted and secured to the apex of the beating heart to provide safe access to the interior or interior of the heart. The devices provided herein provide access to the interior of the heart via the apex without blood loss around instruments introduced into the heart. The transapical cardiac ports provided herein can be used during surgery in which the patient's heart continues to beat. The transapical cardiac ports provided herein can be used to insert various types of instruments into the heart. For example, annuloplasty rings, prosthetic valves, valve clips, cardiac assist components can be inserted into the heart, such as by using the exemplary delivery system (7) shown in FIGS. 20A and 20B.

In an example, the access device has a wet zone (30) from the heart chamber (20) and a dry zone with a "gaseous environment" simultaneously within the patient's body, such as outside said heart chamber, as defined below. It includes an apical baseplate and sealing unit (3) configured to provide isolation of (32).

The sealing unit (3) is not included in the hemostasis valve, or is part of the hemostasis valve but rather a separate entity, as defined herein.

In some cases, the transapical cardiac ports provided herein can be inserted into the apex using, for example, an open surgical incision or through the skin. In some cases, the transapical cardiac port itself provides safe access so that instrumentation can be exchanged during intracavitary surgery without fear of losing apical control. (eg, to prevent bleeding through or around a transapical cardiac port and maintain blood pressure in the patient).

The transapical cardiac ports provided herein are intended to remain permanently implanted in place after completion of surgery performed on the heart. Sealed access to the interior of the heart is provided in several configurations.

The access device (1) has, for example, in one embodiment, a first, open patient (body) configuration. An open patient configuration means that the patient's body is opened for surgery, often through an incision in the patient's skin, and during surgery, as opposed to a closed patient (body) configuration. do. In the example of an open patient body configuration, a removable hemostasis valve unit (2) is removably attached to the proximal side of said apical baseplate (100). In a first configuration, examples include only the hemostasis valve unit (2) is mated with the apical baseplate (100).

The access device (1), for example, in some instances has a second closed patient (body) configuration, wherein the closed patient (body) configuration is such that the patient body is closed after completion of the surgical procedure. means In a closed patient configuration, the sealing unit (3) optionally includes a feedthrough port (320) and is preferably remote to said baseplate (100) to provide separation of wet and dry zones. installed in place. In a first configuration, examples include that the sealing unit (3) is mated with the apical base (100).

In a third configuration of the access device (1), both the hemostasis valve unit 2 and the sealing unit (3) are fitted to the apical base (100). This third configuration is also an open patient (body) configuration. A transition configuration from the first configuration to the second configuration may include a sealing unit (3) inserted into the hemostasis valve unit (2) for delivery to the apical baseplate (100).

The access device including the apical baseplate (100) preferably includes a tubular through port (120) adapted to be placed over the tissue of the heart.

According to one aspect of the present disclosure, an access device for the heart is provided. The device includes an apical baseplate having tubular through-ports that are placed through the tissue of the heart. "Across" means in the present context through the heart tissue and between the inside and outside of the heart. The heart tissue at the apex is thus provided with a tubular port that extends from the outside of the heart tissue to the interior of the heart chamber at the apical region of the heart. This port can be to/from the left or right heart chamber.

The access device has a first configuration in which a removable hemostasis valve unit is attached to the baseplate. The port is thus open for fluid communication and can be closed to prevent bleeding and is controllable by a valve.

Advantages of removable hemostasis valves include, for example, one or more of the following technical effects. It prevents blood leakage while working on the beating heart. Removability allows the installation of units other than hemostasis valves in place of or even in addition to the valve prior to removal of the valve. Other units may have larger dimensions than the opening to the through channel in the hemostasis valve, particularly if the valve housing is provided as divisible to provide a peel off valve. . It can be a reusable valve. If necessary it can be reattached. Especially when the valve housing to be reinstalled is provided as being separable to provide a peel on valve, it can be used in the transitional configuration of the drive unit, valve, base plate, sealing unit. Provide a joint. It provides temporary sealing of access channels of the heart, for example to install an example of a permanent sealing unit (3) adapted to remain implanted. It is to create a separation between wet and dry zones. Reattachable hemostasis valves, e.g., peel-on valves, may be replaced, moved, individually and/or in multiple components, or entire modules, such as bellows (310), or products such as drive units for cardiac support systems. , relocation, repair, and/or upgrade possibilities. Examples of removable and reattachable hemostasis valves can be seen in Figures 25-25E. In Figures 25A or 25D, an example hemostasis valve is illustrated in an assembled state, and in Figures 25B, 25C, and 25E, an example hemostasis valve is illustrated in an exploded state, respectively. Parts (202, 204) illustrate some of the divisible parts of the hemostasis valve.

As used in this disclosure, "wet-dry zone" refers to the separation of the wet zone, i.e. the blood-containing zone within the heart chamber, from the dry zone, i. including, but in each case simultaneously separating within an intact body.

A gaseous environment is provided, for example, outside the heart chamber, with reference to the example illustrated in FIG. 23, there is a gaseous environment inside the drive unit (6).

Additionally or alternatively, a gaseous environment may be provided inside the heart chamber, sealed from the wet zone (see e.g. Figures 11C, 23), where the sealing unit (3) has a gaseous environment inside it and is tightly sealed from the blood in the heart chamber, ie isolated from the wet zone.

Additionally or alternatively, a gaseous environment may be provided inside the transapical foramen (see for example FIG. 11C, FIG. 23), wherein the sealing unit (3) provides a gaseous environment of

Alternatively, or additionally, the gaseous environment may at least partially contain a liquid to provide a "gaseous" environment containing a different medium than blood, e.g. biocompatible lubricating media and/or protective gases or mixtures thereof, such as aerosol particles in gases, to improve the operational life of mechanical components. As long as the "gaseous" environment of the dry zone is tightly sealed within the patient's body from the wet zone containing the blood, it is the "gaseous" environment as used in this disclosure.

A wet-dry zone can therefore be provided during permanent implantation of a medical device, such as an apical baseplate, in a closed patient's body.

The access device has a second configuration in which a sealing unit with a feedthrough port (320) is attached to the baseplate. A feed through port provides separation of the wet and dry zones. A membrane bellows, such as comprising silicone (or other synthetic material such as PVC, polyurethane, etc.), is provided to separate the wet zone from the dry zone. A membrane may consist of one or more membranes or bellows to form a membrane into a membrane solution or a bellows into a bellows solution. Among the bellows of the bellows solution, different bellows may consist of different materials. Different materials may have different properties, such as different particle permeability. In this way, a more efficient "whole" membrane can be applied and/or created. The various bellows may also be made of the same material, for example to create additional safety if one bellows may fail and/or leak, which allows gas leakage may be prevented. A feedthrough port means that the device travels to and from the wet zone over the dry zone. A feedthrough port (320) is provided, for example, at the distal end portion of the sealing unit (3). A sealing member (326), such as an O-ring, may be provided to provide a seal to the feedthrough port. Alternatively, the feedthrough ports may be closed membranes, eg, for magnetic coupling, without sealing members, as shown in FIGS. 24A, 24B, and 24C. In this second configuration, the port is closed to fluid communication by a sealing unit. However, in this configuration a feedthrough port is provided, eg for a medical device. The sealing unit allows separation of wet/dry zones.

Some examples of the sealing unit (3) include e.g. a membrane, e.g. provides separation of the blood in the heart and the dry zone, the extracardiac gas/air environment, at the same time without leakage of blood or gas beyond the separation. Such a sealing unit (3) provides for blood and/or gas retention to delay and/or prevent blood or gas traffic across the separation, for example in the event of membrane dysfunction. may include a detaining unit (330) for In a specific example, the retention unit delays blood or gas leakage if, for example, the bellows (310) may break or malfunction. In some instances, the indwelling unit is made of a sponge or spongy material to allow for slowing or inhibiting leakage of gas into the blood or vice versa. In another example, an indwelling unit may include a three-dimensional maze that allows gas to pass freely but is retarded and/or completely prevents blood from passing through the maze. The detention unit may be located inside the sealing unit (3). For example, an internal channel of bellows (310) may be provided with a retention unit. Alternatively or additionally, the detention unit may be provided on top of the sealing unit (3) (inside the tubular through-port (120), for example sealing as illustrated in FIG. 22B). located in the interior space of the tubular through-port (120) inside the stop unit (3) when assembled). A detention unit consisting of a labyrinth will result in detention of blood and cause detention of gas, thus slowing and/or preventing traversal beyond separation of blood or gas. In another example, due to the mounted design of the retention unit, the retention unit provides controlled leakage and/or breakdown of gases in the blood, or vice versa. An indwelling unit may, for example, be constructed as a diffuser that spreads gas into liquids in a controlled manner for dissolution into blood. The indwelling unit prevents or slows potential gas leakage into the patient's blood stream, or slows or avoids potential blood leakage into the device. Improve patient safety. Regarding this situation, it should be noted that the small amount of gas released over time is not harmful or may dissolve in the blood and is not dangerous to the patient. On the other hand, the same amount of gas released momentarily could be life-threatening, but this is avoided by the detention unit.

A sealing unit with a bellows allows for example longitudinal and/or axial movement of medical device parts relative to each other, for example piston or rod motion. The sealing unit with bellows additionally or alternatively allows radial movement of the device parts relative to each other, in particular from outside the heart to inside the heart, while wet/dry separation is maintained. do.

The sealing unit advantageously provides separation between wet and dry zones.

The sealing unit may be provided with a magnetic coupling, as shown in the examples of Figures 24A, 24B and 24C. Magnetic coupling allows easy assembly and/or easy separation of implanted system components, such as for replacement, addition, removal, or repair of such components. It provides total sealing of the feedthrough port without through channels.

According to another aspect of the present disclosure, a hemostasis valve unit is provided. The valve unit has a housing with a distal end and a proximal end. It is removably connectable at the distal end to the apical baseplate of an access device for the heart. The valve unit includes a pneumatic valve in a through channel of the valve unit between the distal and proximal ends. If necessary, the valve can be reattached for later access, eg, replacement/repair of components of the cardiac assist system. The advantages of removable valves have already been explained above and are also compatible with this aspect.

According to yet another aspect of the present disclosure, an applicator tool is provided for creating a transapical passageway in a beating heart. The applicator tool (herein referred to as the "tool" for short) includes, in some examples, a tissue clipper that can be inserted through a tube of the applicator tool. The tissue clipper has a distal tip for penetrating heart tissue at the apex of the heart. The tube has a sharpened edge at the distal end for dissecting heart tissue at the apex. The tissue clipper has an expandable flange, particularly to prevent retraction of the tissue clipper through the tissue of the heart while dissecting in the tube to provide a complete cut, which in use is the cutting edge of the tube. where the flange is configured to retain severed heart tissue within the tube.

Some examples of the present disclosure provide applicator tools with improved patient safety such that embolism of severed heart tissue is prevented. The tissue to be severed is held securely within the tube with the tissue clipper's flange or wire mesh to retain the tissue within the tube. Complications such as stroke are minimized or avoided by such an example of an applicator tool for creating a transapical passage in a beating heart, which is associated with heart motion and is a particular challenge because of the difficulties associated with containing the cut tissue and preventing it from, for example, being carried aloft in the bloodstream of a beating heart. The tool is advantageous because it provides prevention of blood leakage from the heart chamber when creating the transapical passageway. Penetration through the tissue of the heart to the heart chamber, eg, the apex, is acknowledged as complete by the operator, eg, by integrated blood indicator (490). Also, the access device is deliverable on the same tool that prepares the perforation, thus providing a shortened and safer medical procedure. The tool provides reproducible, desired pore sizes. The applicator tool avoids undesired transapical incisions, eg, too large or too small. The applicator tool enables reproducible medical procedures by assisting the medical professional with preconfigured sequences during implantation. The tool enables a safe medical procedure with reduced overall patient risk compared to manual foraminal dissection with a scalpel in myocardial tissue.

According to yet another aspect of the present disclosure, an applicator tool for creating a transapical passageway includes a tissue cutter insertable through a coaxial dilator of the tool. The tissue clipper has a distal tip for penetrating heart tissue at the apex of the heart. Dilators provide dilation of heart tissue. The applicator tool further includes a cardiac access device having a tubular through port that is positioned through the tissue of the heart when advanced through the dilator.

The applicator tool has the same advantages as mentioned above for the previous tools, except that the tissue to be cut is a tissue clipper flange or wire mesh for retaining the tissue within the tube. , is not retained in the tube.

According to yet another aspect of the present disclosure, a transapical access system for creating a transapical passageway in a beating heart is provided. The system includes an access device for the heart according to aspects previously described in this disclosure. Additionally, the system includes an applicator tool according to aspects previously described in the present disclosure for creating a transapical passageway and delivering an access device to the apex, as described above. The system may provide all or some of the advantages and technical effects of its components described herein.

According to yet another aspect of the present disclosure, a medical system includes a transapically implanted cardiac assist unit. A cardiac assist unit is attachable to the sealed access device. The access device provides wet/dry zone separation within the body. The auxiliary unit is arranged on the dry side. Implantation and assembly of the system is advantageously easy as bleeding is avoided during and after implantation. Since blood cannot enter the auxiliary device, the auxiliary device can be implanted inside the body. The mechanical parts of the ancillary device placed in the dry zone are protected from blood, resulting in increased longevity and reduced risk of complications such as blood clotting, infection and the like. When placed in the dry zone, the electronics inside the auxiliary device are protected from short circuits.

According to yet another aspect of the present disclosure, a sealed apical baseplate is provided, said apical baseplate including a connection interface for mating engagement of a plurality of medical devices, and said plurality of medical devices. The devices each have a mating connection interface for connection to the apical baseplate.

The connection interface may include a rotatable connection of a system including medical devices associated with the apical baseplate. Rotatableness may include movement in three dimensions about a pivot point. Free rotation, for example, provides flexibility when positioning the medical (auxiliary) device during implantation. Free rotation allows movement of the parts relative to each other after ingrowth when implanted. This avoids trauma such as necrosis, for example, in the connective tissue at the site of implantation. Baseplate mounting spikes are optional, eg, omitted in free-rotation designs, as these mounting spikes may otherwise interfere with free-rotation. Free rotation causes the devices of the system that are connected at the connection interface to continuously attempt to move toward a stress-free position, thus avoiding pulling forces in the implanted system. As such, the system has a long lifespan and high biocompatibility.

According to yet another aspect of the present disclosure, a method is provided for creating a transapical passageway in a beating heart. A method or medical procedure includes determining a location on an apical region for creating a transapical passageway. This step may perform imaging modalities, such as CT-based, MR-based, ultrasound-based, etc., that provide suitable image data for processing and analysis. Alternatively or additionally, the position may be determined by tactile and/or visual inspection of the heart, for example during surgery. The method further includes creating a transapical hole through heart tissue at the determined apical region, such as by drilling and/or cutting through the tissue. The method further includes delivering an access device, such as an apical baseplate having a tubular through port to the transapical hole. The method further includes attaching a flange unit of an access device to the outside of the heart and removably coupling a hemostasis valve unit to said access device. The method allows advantageous creation of wet zone/dry zone separation in the body. The method facilitates access to heart chambers for various surgical and/or medical devices. The method and associated devices allow for the safe creation of a passageway through the tissue of the heart, such as a transapical passageway, while removing a volume of tissue removed for passage, such as a perforation through the heart tissue. prevent intrusion. The methods and devices used effectively prevent bleeding. The methods and devices used provide reproducible pore sizes. Although the methods and devices used avoid overly large incisions of the transapical foramen, it presents a therapeutic challenge. Because the method must be performed in a preconfigured sequence as given by the device used, a reproducible medical procedure is provided to assist the medical professional during implantation. Overall, the method enables a safe medical procedure with reduced risk for the patient.

According to yet another aspect of the present disclosure, a method of implanting a medical device, such as a cardiac assist system, on a transapically beating heart is provided. A method or medical procedure includes attaching a medical device, such as a cardiac assist unit, to a sealed access device. A medical device, such as an ancillary unit, removably attached to a sealed access device has many advantages. For example, removable devices provide an extended useful life of the overall implanted system due to replaceable and/or repairable units. The implanted system can be easily updated with future improved or enhanced devices. Repeated access to heart chambers is provided through permanently implanted access devices. Also, the removable medical device can be removed when no longer needed (successful patient treatment).

Further embodiments are defined in the dependent claims.

1A and 1B illustrate examples of access devices for the heart. 1A and 1B illustrate examples of access devices for the heart. Fig. 10 is a plan view of a template (190) for positioning an access device (1); Figures 3A and 3B illustrate the hemostasis valve unit (2). Figures 3A and 3B illustrate the hemostasis valve unit (2). Figures 4A and 4B illustrate the inflatable balloon configuration of the hemostasis valve unit. Figures 4A and 4B illustrate the inflatable balloon configuration of the hemostasis valve unit. Figures 5A-5C illustrate a first configuration of the access device (1). Figures 5A-5C illustrate a first configuration of the access device (1). Figures 5A-5C illustrate a first configuration of the access device (1). Figure 1 illustrates the implanted access device (1) in a first configuration. Figures 7A and 7B illustrate a sealing unit for mounting on the access device (1) to provide the second configuration. Figures 7A and 7B illustrate a sealing unit for mounting on the access device (1) to provide the second configuration. Figures 8A and 8B and Figures 9A and 9B illustrate the transition from the first configuration to the second configuration of the access device (1). Figures 8A and 8B and Figures 9A and 9B illustrate the transition from the first configuration to the second configuration of the access device (1). Figures 8A and 8B and Figures 9A and 9B illustrate the transition from the first configuration to the second configuration of the access device (1). Figures 8A and 8B and Figures 9A and 9B illustrate the transition from the first configuration to the second configuration of the access device (1). Figures 10A-10B and 11A-11B illustrate a second configuration of the access device (1), particularly an example of a sealed access device (1), where multiple medical devices are mated. A connection interface (110) is included for purposefully engaging. Figures 10A-10B and 11A-11B illustrate a second configuration of the access device (1), particularly an example of a sealed access device (1), where multiple medical devices are mated. A connection interface (110) is included for purposefully engaging. Figures 10A-10B and 11A-11B illustrate a second configuration of the access device (1), particularly an example of a sealed access device (1), where multiple medical devices are mated. A connection interface (110) is included for purposefully engaging. Figures 10A-10B and 11A-11B illustrate a second configuration of the access device (1), particularly an example of a sealed access device (1), where multiple medical devices are mated. A connection interface (110) is included for purposefully engaging. Figure 10 illustrates an implanted access device in a second configuration; FIGS. 12A and 12B illustrate an example of an applicator tool for creating a transapical passageway in a beating heart, for example, using a tube with sharpened edges terminating in an open A grip with lock is shown. FIGS. 12A and 12B illustrate an example of an applicator tool for creating a transapical passageway in a beating heart, for example, using a tube with sharpened edges terminating in an open A grip with lock is shown. Figures 13A-13D illustrate a tissue clipper needle, a rod with a retention unit in the form of an expandable barb, and a piercing tube with a sharp end edge assembly in various configurations. . Figures 13A-13D illustrate a tissue clipper needle, a rod with a retention unit in the form of an expandable barb, and a piercing tube with a sharp end edge assembly in various configurations. . Figures 13A-13D illustrate a tissue clipper needle, a rod with a retention unit in the form of an expandable barb, and a piercing tube with a sharp end edge assembly in various configurations. . Figures 13A-13D illustrate a tissue clipper needle, a rod with a retention unit in the form of an expandable barb, and a piercing tube with a sharp end edge assembly in various configurations. . 14A-14C illustrate the creation of a transapical perforation in the heart with the applicator tool shown in FIGS. 12 and 13. FIG. 14A-14C illustrate the creation of a transapical perforation in the heart with the applicator tool shown in FIGS. 12 and 13. FIG. 14A-14C illustrate the creation of a transapical perforation in the heart with the applicator tool shown in FIGS. 12 and 13. FIG. Fig. 4 illustrates details of the applicator tool; Fig. 4 illustrates details of the applicator tool; FIG. 12 illustrates the applicator tool in a configuration in which a transapical puncture is performed and the tissue plug is safely retracted within the tool's tube. FIG. Figure 10 illustrates an applicator tool with a dilator; Figures 19A and 19B illustrate an example of a transapical access system (5) assembled and ready for use, including an applicator tool, an access device for the heart, and a hemostasis valve. Figures 19A and 19B illustrate an example of a transapical access system (5) assembled and ready for use, including an applicator tool, an access device for the heart, and a hemostasis valve. 20A and 20B illustrate an intracardiac delivery device for a medical device that is insertable through the hemostasis valve and access device in a first configuration. 20A and 20B illustrate an intracardiac delivery device for a medical device that is insertable through the hemostasis valve and access device in a first configuration. Figures 20A and 20B illustrate the delivery device of Figures 20A and 20B inserted transapically into the heart through a hemostasis valve and an apical access device in the first configuration described herein. Figures 22A and 22B illustrate an example of a medical system including a transapically implanted cardiac assist unit attachable to a sealed apical baseplate. Figures 22A and 22B illustrate an example of a medical system including a transapically implanted cardiac assist unit attachable to a sealed apical baseplate. 1 illustrates an implanted access device with a sealed apical baseplate and an attached cardiac assist unit. Figures 24-24C illustrate alternative sealing units with magnetic coupling. Figures 24-24C illustrate alternative sealing units with magnetic coupling. Figures 24-24C illustrate alternative sealing units with magnetic coupling. Figures 25A-25E illustrate a splittable hemostasis valve unit. Figures 25A-25E illustrate a splittable hemostasis valve unit. Figures 25A-25E illustrate a splittable hemostasis valve unit. Figures 25A-25E illustrate a splittable hemostasis valve unit. Figures 25A-25E illustrate a splittable hemostasis valve unit. 4 illustrates steps of an example method of creating a transapical passage in a beating heart. 4 illustrates steps of an example method of transapically implanting a cardiac assist system. Figures 28A-28F illustrate examples of apical baseplates. Figures 28A-28F illustrate examples of apical baseplates. 28A-28F illustrate examples of apical baseplates Figures 28A-28F illustrate examples of apical baseplates. Figures 28A-28F illustrate examples of apical baseplates. Figures 28A-28F illustrate examples of apical baseplates.

Specific examples of the disclosure will now be described with reference to the accompanying drawings. The invention contained herein may, however, be embodied in many different forms and should not be construed as limited to the examples set forth herein, but rather those examples is provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. The terminology used in the detailed description of the examples illustrated in the accompanying drawings is not intended to be limiting of the invention. In the drawings, like numbers refer to like elements.

Referring now to the drawings, Figures 1A and 1B illustrate an example of an access device (1) for the heart, Figures 5 and 6 illustrate a first configuration of said access device, and Figures 10 and 11 illustrate a second configuration of the access device (1).

The access device (1) includes an apical baseplate (100) having a tubular through port (120) that is placed through the tissue of the heart at the apex (12) of the heart (10). The heart tissue at the apex (12) is thereby provided with a tubular through port (120) extending from the exterior of the heart tissue (14) to the interior of the heart chamber (15) at the apical region of the heart (10). This port can be left-to-right or right-to-left in the heart chamber (10) depending on its location in the apical region.

For example, mounting spikes (150, 151) are provided in the access device to receive mating holes or recesses (250, 251) in the valve unit (2) or cardiac assist drive unit (6). This allows for precise rotational mounting of the unit relative to the access device when the mating pairs of spikes and holes have different shapes.

Alternatively or additionally, a locking member, such as a bayonet joint (155), is provided for locking the unit once, or in combination with mounting, to the access device (1). may be provided.

The apical baseplate is preferably made of a rigid, preferably biocompatible material. A flexible flange (160) of the access device (1) allows coupling to cardiac tissue outside the heart (10). Flange (160) is made of a biocompatible woven material, such as, for example, a woven or non-woven material. Suitable medical materials are eg Dacron or PTFE. The flange unit (160) is attachable to the outside of heart tissue by suitable attachment elements. Attachment elements are preferably sutures, hooks, clips, staples and/or screws or the like. The flange includes, for example, a small ring for receiving suture material for suture attachment of the access device (1) to the heart. Suture (165) is shown diagrammatically in FIG. 11C. The access device (1) is thus securely attached to the heart, while bleeding from the heart chamber outside the duct between the heart tissue and the tubular penetration port (120) is sealed. protected by a flange. When the transapical access system is withdrawn from the hemostasis valve, bleeding through tubular penetration port (120) is prevented initially by tube (410) during suturing or by the hemostasis valve.

Alternatively or additionally to the use of the tool (4) to create the transapical hole, the hole can be made with conventional surgery using a scalpel. However, this will result in more bleeding than using the tool (4).

A tubular through port (120) protrudes from the apical baseplate (100) and is inserted into a transapical foramen made in a suitable manner. Preferably, the tube of tubular through-port (120) has an outer diameter slightly larger than the transapical foramen to improve sealing when applied.

Flange (160) is attached, for example, to apical baseplate (100). The base plate may be made of two plates, and flanges are placed between them upon mounting of the plates, as shown by the screws in the base plate (100) in the illustrative figure. clamped together (see also FIG. 11B).

An example of an apical baseplate is illustrated in Figures 28A, 28B, 28C, 28D, 28E, and 28F. Figures 28A and 28B illustrate the apical baseplate. FIG. 28C shows a plan view of the apical baseplate. FIG. 28D shows an enlarged view of the apical baseplate. FIG. 28E illustrates a cross-section of the apical baseplate. FIG. 28F illustrates the apical baseplate with two holders connected.

In the example, the apical baseplate includes suture holes (170) to facilitate attachment to the subject. Flange (160) may be attached to the apical baseplate by sutures.

As such, the access device may, in use, be attached to heart tissue while sealing the interior from the exterior of the heart. Flange (160) may be sutured to heart tissue, eg, with a parachute technique, ie, the suture is first secured to the tissue, eg, at the desired apical location by template (190). The flange of the access device is then passed over the suture and pushed along the suture to the heart tissue. The access device is then advanced across the tube (410) occupying the hole in the heart wall until the plate and flange are in contact with the heart surface, and the distal opening of the tube at the tubular through port (120). is inside the heart chamber. The hemostasis valve (2) is coupled to the apical baseplate (100) during attachment to the heart. Finally, the suture is knotted and the flange (160) is thereby secured to the tissue so that blood inside the heart does not leak past the access device (1) and access device (1) Bleeding through 1) is prevented by a hemostatic valve. Alternatively or additionally to the parachute techniques and/or sutures described, tissue glue, staples, hooks, clips, or other fastening means hermetically affix flange (160) to heart tissue. may be used for When the access device (1) is properly attached to the apex, port (120) is the only fluid communication.

The access device (1) may then be permanently left in place avoiding the need to close the transapical foramen after surgery. Access devices, as described herein, allow advantageous access to heart chambers.

The template (190) shown in FIG. 2 has an outer perimeter corresponding to the perimeter of the flange unit (160). Thus, the appropriate cardiac surface at the apex can be determined by applying the template (190) to the apical region. The template (190) has markings, for example in the form of indentations (191), corresponding to elements of the access device (1), for example holes corresponding to the outer diameter of the tubular through-port. Such an indentation or similar indicia may be sutured to the heart tissue and affixed to the access device (1), e.g., by sutures, e.g. Allows correct orientation to the apex when attached. The template (190) preferably includes holes (192) for suture stitching to securely attach the access device (1) to the apex of the heart at a suitable surface for creating a transapical passageway through the heart tissue. )including.

Alternatively or additionally to the template (190), the precise location for implanting the access device (1) is determined manually by the surgeon's tactile and/or imaging (e.g., ultrasound-based guidance). may be found in

The access device (1) has a first configuration in which a removable hemostasis valve unit (2) is attached to the baseplate. A first configuration is illustrated, for example, in FIGS. 5A, 5b, and 5C, and FIG. Port (120) is thus open to fluid communication and can be controlled by valve (2) when attached. The valve (2) is (re)attachable or mountable to the baseplate (100) by suitable attachment means. For example, mounting can be done with a threaded attachment (rotation of the devices relative to each other), screws, bayonet locks, and the like. The valve (2) is for example at the end of a procedure performed through the valve and the access device (1) or because the access device (1) is sealed with another unit, for example the sealing unit (3). When transitioned to a second configuration where the valve is not required, it is re-attachable from the baseplate. The removable hemostasis valve (2) has a valve-penetrating port with proximal and distal openings, e.g., for delivery of various sized medical devices into the heart (heart chamber) , and from the interior of the heart (chamber) with a controllable orifice size.

The access device has a second configuration in which a sealing unit (3) with a feedthrough port (320) is attached to the baseplate (100). A second configuration is shown, for example, in FIGS. 10A and 10B and FIGS. 11A, 11B, and 11C. In this configuration, port (120) is closed to fluid communication by a sealing unit. However, a feedthrough port (320) for a medical device, for example, is provided in this second configuration of the access device (1). The through-port preferably has a sealant (326) to prevent blood from leaking out of the heart. The sealing surface at the inner portion of the tubular through-port is the sealing member (325), such as at the proximal end thereof, such as at the outside of the sealing unit, such as at the proximal end shown in FIGS. 1A and 1B. ). This prevents blood leakage through the penetration port when the sealing unit (3) is inserted and applied to the access device (1).

A second configuration of the access device (1) is provided alternatively or in addition to its first configuration. A second configuration of the access device (1) is such that during transition from the first configuration to the second configuration, for example, the sealing unit (3) seals the hemostasis valve unit attached to the apical baseplate (100). It may be provided in addition to the first configuration only when delivered to the apical baseplate (100) via. This has the advantage of avoiding blood leakage when changing the configuration of the access device (1). The transition from the first configuration to the second configuration is illustrated, for example, in Figures 8A and 8B. Coexisting first and second configurations are illustrated, for example, in FIGS. 9A and 9B.

As can be seen in Figures 8A, 8B, 9A, 9B, the sealing unit (3) of the access system, for the transition from the first configuration to the second configuration, is illustratively a hemostasis valve unit. (2) configured to be delivered through; In a second configuration, a separation is provided between wet and dry zones.

The hemostasis valve unit (2) may include one or more units for controlling the opening cross-section or opening of the port (210) of the valve. The one or more units that control these openings may, like the housing (200), for example, peel-on and/or peel-off units as described herein. may be divisible for Dividability is preferably provided by a structure in which at least two parts are joined to form a unit. For example, mechanical or magnetic, preferably releasable joints can be provided at the joints. In particular, as shown in the figure, the housing parts are preferably split axially/longitudinally of the valve unit (2). As such, the housing parts are preferably removable radially outwardly in what is referred to herein as a "peel-off" operation. Other unit(s) may provide sealing of the wet and dry zones of the apical baseplate, such as the bellows described herein. Reassembly may be performed by reverse assembly of such housing parts of the valve unit (2) radially inwards, also referred to herein as a "peel-on" operation.

For such control, the unit may be moved or dimensioned appropriately. Examples of units include inflatable balloons, leaflets (movable or stationary), flaps (movable or stationary), and the like. The aperture may be controlled by a unit such as a camera lens aperture stop or an iris-like unit. The unit may alternatively or additionally include directional flow control elements, such as valves. Controlled directional flow can be unidirectional, ie, only one direction, or bidirectional, ie, two directions (forward, backward flow).

Figures 3A and 3B show the hemostasis valve unit (2) and Figures 4A and 4B show examples of two different inflatable balloon configurations for the hemostasis valve unit (2). A removable hemostasis valve is connectable to the through port (120), ie, a fluid communication channel is provided to the through channel (120) through the hemostasis valve. Hemostasis valve (2) may, for example, include one or more sealing elements (not shown) suitably positioned relative to access device (1). For example, such a sealing element may be provided to press against the proximal side of the apical baseplate and/or the proximal end portion of the tubular through-port (120).

The hemostasis valve unit (2) includes a housing (200) having a proximal end and a distal end. Housing (200) may be splittable for peel-on and/or peel-off of hemostasis valve unit (2), eg, as described herein. The distal end is affixable to the access device (1). Both ends contain openings for access to the through channels of the valve (2). The through channel contains an inflatable balloon via an inflation port (210). The inflation pressure provides a more or less restricted passage through the through channel of the valve (2), i.e. the orifice of the valve through port (225) is variable with the inflation pressure (illustrated by the double headed arrow in FIG. 4A). as per). Devices inserted into the through channel may have different diameters and cross-sectional shapes, where the balloon pressure conforms to this cross-section to achieve a reliable seal. Thus, the through channel of valve (2) accommodates a wide variety of device diameters and cross-sectional shapes. As shown in FIG. 4B, the balloon (220) allows passage through the through channel of the valve (2) while safely providing a positive seal and leak prevention of blood from the interior of the heart to the exterior of the heart. It may also have multiple lobes to improve adaptability to different diameter ranges or cross-sectional shapes of the adaptable device.

Hemostasis valve unit (2) is shown removably attached to access device (1), for example in FIGS. 5, 6, 8 and 9. FIG. A sealing surface (230) is provided for a fluid tight seal to the sealing surface (130) of the access device (1), such as at the apical baseplate (100). Seals may include sealing members such as O-rings for improved sealing.

The hemostasis valve may be removably and securely affixed to the access device (1) via a bayonet fitting (155), eg, including a bayonet pin (255).

As shown in Figures 25A, 25B, 25C, 25D, 25E, the housing (200) of the valve (2) can in some instances be split and (202, 204) are the Dividable housing parts of the valve (2). Thus, the valve (2) can be disassembled from the parts located at the through port (225). Blood leakage may be effectively prevented by other components, for example, as shown in FIG. 24A. The access device (1) with the sealing unit (3) applied provides bleeding prophylaxis as described above. With a medical device having a larger proximal diameter than through-port (225), valve (2) is not pulled proximally for removal from the whole. There may be mechanical obstacles against valve (2) being retracted. For example, the drive unit (6) may be affixed proximally to the assembly of the access device (1) and sealing unit (3) as shown in Figure 24A. The splittable valve (2) may then be conveniently removed from the assembly by deflating the balloon (220) and splitting the valve (2) once the other parts have been assembled. The valve (2) is arranged to be peeled off. The valve (2) segments can then be removed from the patient when the valve (2) is no longer needed. Alternatively or additionally, the divisible valve (2) can only be opened while the parts are still connected to each other. For example, two adjacent parts of a divisible valve having several parts are separated from each other to open the divisible valve (2) and at the same time, e.g. hinges, splints, strings or similar It has parts that are still joined by a connecting member (such as an open ring). Alternatively or additionally, the valve (2) can then be reassembled and reassembled, e.g. It can be reattached to the baseplate (eg peel-on).

The peel-on and peel-off embodiments of the hemostasis valve (2) may be applied vice versa for each of these procedures, respectively.

The valve (2) may later be put into a configuration such as that shown in FIG. 24A when sealing is desired again, for example due to repair or replacement of components of the assembly or other parts of the system. It may be reattached. The access device (1) thus allows re-access to the interior of the heart (15) at a later time.

The access device (1) may include a cardiac assist device drive unit (6) connected to the baseplate in a second configuration. Rods (610) (FIGS. 11A and 23) may transmit motion generated by the drive unit into the heart chambers for cardiac assistance. The distal end of rod (610) may be coupled to an anchor at the heart valve region, such as anchor unit (650) in the example of an annuloplasty implant.

An anchor unit in the form of an annuloplasty implant is described in unpublished PCT application PCT/EP2019/068597 filed on July 10, 2019, of the same applicant, and for all purposes is disclosed in its entirety. is incorporated herein by reference, particularly in the description of the chain annuloplasty ring and delivery system shown in FIGS. 24-42, and the corresponding specification.

The coupling of the rods can be done magnetically, for example using a sealing unit (3) shown in Figures 24A, 24B, 24C. A magnetic coupling (340) at the distal end of the sealing unit provides an advantageous coupling with a rigid link at the coupling point that allows rotational movement and motion accommodation. A hollow in the magnetic coupling may be provided as a recessed funnel to receive the spherical ball coupling, which may allow this movement and geometrical adaptation during assembly and operation of the auxiliary unit. Such a magnetic clutch connection offers many advantages, such as overload protection. Magnetic connections can be configured to separate at a predetermined threshold force to avoid tissue damage. The possibility of decoupling the magnetic clutch also allows easy repair of the auxiliary system components, eg their repair, replacement or removal.

Coupling means are described in unpublished PCT application PCT/EP2019/068597 filed on Jul. 10, 2019, of the same applicant, which is hereby incorporated by reference in its entirety for all purposes. includes, inter alia, a description of the connection unit (200) and the extension unit (400), for example the joint connection linked with the magnetic bodies as shown in Figures 5 and 6, and the corresponding specification.

7, 8, 9, 10, 11, 22, 23 and 24 show examples of sealing units (3) in various configurations.

The sealing unit illustratively includes a membrane or bellows (310) and a feedthrough port (320). Feedthrough ports may be completely sealed with no openings to pass through, such as due to magnetic coupling. Alternatively or additionally, the feedthrough port may have a distal opening for feeding through elements such as rod (610). The distal opening is then provided with a sealing member (326), such as an O-ring, to seal the feedthrough port to provide separation of the wet and dry zones while at the same time Allows motion to be transmitted. The sealing unit thus allows, for example, reciprocating motion, eg, in the placement of a cardiac assist/drive unit, for safe, leak-free reciprocating motion over hundreds of thousands of repeated cycles.

The membrane or bellows is in some examples preferably made of an elastic and/or flexible material, such as silicone. Bellows may be made of a biocompatible metallic material such as titanium or nitinol. The bellows is longitudinally movable, for example for reciprocating periodic motion. It is also radially movable, allowing free motion or rotation as described herein. In some instances, as the bellows moves longitudinally in operation, the bellows rotates simultaneously. Thus, there may be a rotation that causes the bellows to reciprocate forward and backward, as well as a kind of screw or corkscrew-like action. This combined movement can be achieved, for example, by such elastic and/or flexible material of the bellows. A bellows that permits rotation can have advantageous features because it mimics the natural muscle contractions that produce spiral heart motion. Such advantageous features can be, for example, lower friction of the bellows. Other advantageous features are, for example, less stress and tension on the bellows, resulting in longer bellows life.

If it is desired that the through channel be closed, this may be done by a plug (not shown) that can be inserted into the through port (120).

3, 4, 5, 6, 8, 9, 19, 20, 21, 24 and 25 are diagrams showing examples of hemostasis valve units (2) of various configurations. be.

The hemostasis valve unit (2) includes a housing (200) having a proximal end and a distal end. It is removably connectable at the distal end to the apical baseplate (100) of the access device (1) for the heart (10). The valve unit (2) includes a pneumatic valve in a through channel (225) of the valve unit (2) between the distal and proximal ends.

A pneumatic valve is, for example, a balloon valve or a tubing coil for controlling an inner passageway in a through-channel of the valve. Balloon valves generally have a greater extent than tubing coils and, alternatively, the height of the valve can be reduced. A balloon valve is shown diagrammatically in FIG. 4, while the valve shown in FIG. 25 may have a tubing coil for control of the flow path in the through channel.

Housing (200) has a proximal end with an opening to through port (225) of valve unit (2), such as for receiving a medical device passed through the internal flow path of valve unit (2). .

Hemostasis valve unit (2) may, in some examples, include a pneumatic reservoir unit (not shown) to maintain a substantially constant pressure at the pneumatic valve.

In some examples, housing (200) is splittable. It has, for example, a plurality of divisible housing parts (202, 204). It is shown in FIG. This allows for the advantageous peel-off described herein when the valve is split.

The valve unit (2) may be reusable.

In FIG. 4A, a single-lobed "doughnut" balloon is illustrated.

In FIG. 4B, a balloon (222) with multiple lobes is illustrated.

The inflation port (210) is connectable to a pressure regulation source for controlling the pressure in the balloon. Different pressures result in different pressures for different expansions of the balloon and for devices introduced into the through port (225) and apposed to the outer wall of the balloon. Sealing is thus ensured over a wide cross-section of the device entering through port (225). For example, a small needle or relatively large tube can enter through the valve without bleeding.

In FIG. 5 the valve (2) is shown attached to the access device (1). This assembly is attached to the heart (10) and is illustrated in FIG. 6 to create transapical access to the heart chambers.

In FIGS. 19A and 19B the hemostasis valve (2) is shown attached to the applicator tool (4) over tubing (410) and in FIGS. It is shown attached to a delivery system (7) for delivering the medical device to the. Delivery tube (70) of delivery system is configured to be inserted into heart chamber (20). A delivery tube (70) is shown inserted through an access device (1) with an attached valve (2) (see FIG. 6) in some instances. The distal end of delivery tube (70) is advanced through the left ventricular chamber toward the left atrial chamber in some instances. Pusher (74) may be used to advance a medical device or other medical system assembly component through delivery tube (70) and into the heart. The delivery system may include a funnel-shaped inserter unit (72) to facilitate insertion of such devices and components into the proximal end of delivery tube (70). For example, anchor unit (650) may be delivered through delivery tube (70) to the heart valve region, as illustrated in FIG. 21 (at the distal end of delivery tube (70)) and in FIG. (delivered and attached to the valve area and also to the rod (610)). The anchoring unit is, for example, the chain annuloplasty ring implant referred to above and described in PCT Application No. PCT/EP2019/597068 and particularly shown in FIGS. 24 to 42 and corresponding A chain annuloplasty ring and its delivery system set forth in the specification. The annuloplasty ring may be affixed to a heart valve annulus, such as the mitral annulus shown, by a plurality of anchor screws (not shown). These screws are driven by an attached screwdriver (not shown) to the annulus tissue while leaving the proximal end accessible for rotation passed through the lock of the inserter unit (72). may be rotated into

Once anchor unit (650) is installed, drive rod (610) can be attached to anchor unit (650) via access device (1). The rod (610) is placed, for example, through the feedthrough port (320) of the sealing unit (3) and through the hemostasis valve (2) as described herein to the access device (1). placed together in the The rod (610) may be installed first, then the sealing unit (3), with its bellows, covers the rod (610), through the valve (2) and then to Once the drive unit (6) is connected to the drive rod (610) and access device (1), the valve (2) can be removed and the wet and dry zones can be controlled with the cardiac assist system in place on the patient. Keep the isolation implanted.

12-19 show an example of an applicator tool (4) for advantageously forming a transapical passageway in a beating heart, for example having a sharpened edge at its distal end. A tube (410) is provided.

The applicator tool, in some examples, includes a tissue clipper (450) that can be inserted through a tube of the applicator tool. Tissue clipper (450) includes a rod member (470) housed inside a hollow penetrating needle (460) having a distal tip for penetrating heart tissue at the apex of the heart. Rod member (470) is preferably a rigid rod with an expandable retention member (473) at the distal end (472) of the rod. A rod (470) is longitudinally movably disposed within the penetrating needle. A piercing needle is inserted into tube (410) and is longitudinally movably disposed within tube (410). The rod is preferably kept longitudinally stationary with respect to the penetrating needle (460) as it is moved longitudinally. Tube (410) preferably has a sharpened edge at its distal end for cutting heart tissue at the apex.

In a first step, the tube (410) is appose with the distal end at the desired location on the apex. Penetrating needle (460) is pushed out of tube (410), through heart tissue, and into the heart chamber at that location, such as determined by template (190). The needle has a sufficiently small diameter to cause substantially no bleeding through the heart tissue at the puncture site. A tissue clipper (450) is housed within the piercing needle with an expandable flange in a folded configuration inside the needle lumen and near the sharp tip of the needle. See Figure 13A.

The distal end of tube (410) can be appose to the desired apical region and then a penetrating needle can be pushed through the apex. For example, a penetrating needle may be releasably activated by a trigger (465). The trigger opens the needle and the needle is pushed forward by spring (466) released by trigger (465). The needle is "shot" through heart tissue in a quick and reliable manner.

Figures 15 and 16 show details of the applicator tool (4). More precisely, the proximal portion of penetrating needle (460) is shown housing the proximal end portion of rod (470). Rod (470) has a shoulder (471) such that the rod is longitudinally movable relative to penetrating needle (460). The shoulder provides a stop in the proximal direction so that the relative position of rod (470) to penetrating needle (460) is defined in the retracted position of rod (470), e.g. ) is seen withdrawn into the distal tip of rod (470). The needle seat (461) pulls the trigger while pushing the needle (460) and rod (470) assembly forward, for example, activates the needle trigger (465) and the needle spring is in tension. By releasing (466) they are shot forward together. See FIGS. 15, 17, or 19A and 19B. A safety pin (467) may be provided to prevent unintentional activation of trigger (465). Rod (470) can then be moved distally at its distal end out of the distal end of penetrating needle (460) to extend one or more retaining units (473).

Thus, once the penetrating needle is positioned through the tissue of the heart, the tissue clipper (450) may be pushed forward from the penetrating needle distal end. This may be done by pushing proximal end (455) of tissue trimmer (450) in a distal direction while penetrating needle (460) is in place, e.g. As you can see, it's retained. The expandable flange is then expanded, for example by its own elastic force. The flanges thus provide an anchoring element to prevent withdrawal of the tissue clipper through the heart tissue, as shown in FIGS. 13B, 13C, 14B. A moveable and lockable restraining element (474) is used to hold the rod in place relative to gripper (400) and/or tube (410), as illustrated in FIGS. 18 and 19A. may be provided.

The tissue clipper with the extended holding unit is then drawn towards the heart tissue, ie at the inner wall of the heart chamber. A shoulder (471) at the proximal end portion of rod (470) and an enlarged retention unit (473) abut the penetrating needle. As such, collective rod (470) and penetrating needle (460) may be proximally retracted as one unit, for example, by manually pulling proximal end (455) in a proximal direction.

Tube (410) is then pushed forward through the heart tissue toward the retention unit where the flange is cut into tube (410), as illustrated in FIGS. 13D and 14C. configured to maintain the heart tissue. The tube (410) is longitudinally movably arranged and pushed forward in a safe and reproducible manner, for example by using a trigger (415). Trigger (415) may be arranged in the form of a claw (417) that pushes against tube (410) when the trigger is so activated. When depressing the trigger, the claws are slightly angled against the outside of tube (410) and lock in place for the depressing action. Release of trigger (415) decants claw (417), which can then slide back along tube (410) for the next forward triggering action. This allows precise activation of movements with a compact mechanism. Heart tissue cut from the transapical hole thus created is held safely inside tube (410) and is schematically illustrated in FIG. 14C as tissue plug (475).

Tube (410) may be pushed forward, for example, by manipulation of trigger (415) of gripper (400). The tube may be rotatably retained about its own central axis. Cutting may be facilitated by rotation of the tube as it travels through the heart tissue. Rotation of the tube may be provided by a control dial (420). Thus, a quick, accurate, and efficient transapical foramen is created. This is done with improved patient safety by preventing embolism of severed heart tissue. The severed tissue is safely held within the tube (410) with the flange of the tissue clipper within the tube anchoring the tissue, as illustrated in FIG. 13D. Complications such as stroke are minimized or avoided by such an example of an applicator tool for creating a transapical passage in a beating heart, which is associated with heart motion and is a particular challenge because of the difficulties associated with containing the cut tissue and preventing it from, for example, being carried aloft in the bloodstream of a beating heart.

Tube (410) has an outer diameter that substantially corresponds to the diameter of a transapical foramen drilled in heart tissue. When a tubular through-port (120) is placed in the transapical foramen via said tube (410), the outer diameter of the through-port (120) is slightly larger than the diameter of the transapical foramen. The tissue around the transapical foramen is thus resiliently pliable towards the outside of the canal of the through port (120), thus reducing ingrowth and sealing of the access device (1). can improve both.

The distal end of tube (410) is in fluid communication with a proximal seal, which in some examples includes blood indicator (490). Blood entering the blood indicator via tube (410) signals the penetration of cardiac tissue into the heart (10) interior/chamber (20), as illustrated in FIGS. Tutool (4) can also deliver a medical device in some instances. For example, the device may be placed over the outside of tube (410) and slid over tube (410).

A medical device is matingly arranged to be received in a channel inside the device and is slidable over the outside of tube (410). It can be slid from the distal end of the tube onto the tube for assembly, for example, as shown in FIG. 19A. The conical protection unit may be used at the distal end of tube (410), for example to cover sharp edges (412) on the distal end of tube (410), for example, as the medical device is slid over the tube. May be temporarily attached to the orifice.

In FIG. 19B, the device is illustrated being slid forward.

In one example, the device includes an apical access device (1). The device may include a hemostasis valve unit (2) pre-removably attached to itself.

The apical baseplate can be slid forward over the tube (410) and into the through-hole with its tubular through-port (120) and the distal end of the tube inserted through the heart tissue. When the flange unit (160) is sealingly attached to the apex, the applicator tool can be retracted from the port (120) and the valve unit (2). This holds in place the access device assembly with the valve unit (2) attached, as shown in FIG.

The transapical port can then be used, for example, for delivery of devices to the heart chambers or to perform a desired procedure. And finally, a sealing unit (3) can be installed to provide wet/dry zone separation. A medical device, such as the drive unit of a cardiac assist device, can be placed in the dry zone of the access device (1). The valve unit may be removed. The procedure can then be concluded by implanting the device in the closed patient's body, leaving the wet/dry zones separated.

Figure 18 illustrates an example of an applicator tool for creating an apical passageway, wherein said tool includes a penetrating needle that can be inserted through a dilator (480) coaxial with said tool. . Penetrating needle (460) has a distal tip for penetrating heart tissue at the apex of the heart.

This example does not include a tissue clipper. However, a tool (4) having a tissue retaining member based on a tissue clipper as previously described and a cutting tube allows the creation of a hole substantially smaller than a tubular through port (120) (not shown). may make it possible. The diameter of the hole may then be widened by a dilator (480). The applicator tool (4) may further include a cardiac access device having tubular through-ports that are positioned over heart tissue when advanced over the dilator. Also, the removable hemostasis valve unit (2) is attachable to the access device (1) and slidable on the dilator (480) in some of such tools (4). Examples can be included.

Thus, a transapical access system (5) for creating a transapical passageway in a beating heart is provided. The system includes an access device for the heart according to aspects previously described in this disclosure. Additionally, as described above, the system includes an applicator tool for creating a transapical passageway and delivering an access device to the apex of the heart, in accordance with the previously described aspects of the present disclosure.

The system may include a fixture template (190) for targeted drilling of the apex. The fixture may, in some examples, be provided with a patient-specific shape for the apex of a particular patient's heart (10). A particular shape may be selected from multiple pre-manufactured fixtures of various shapes. Template (190) may be manufactured in a specific shape based on imaging data, such as apical data, eg, CT-based imaging data.

FIG. 23 illustrates an example medical system that includes a transapically implanted cardiac assist unit. The drive unit (6) of the cardiac assist unit is shown attached to the sealed apical baseplate (1), where said apical baseplate (1) is implanted as described above. , resulting in wet/dry zone separation in the transapical passage. The mechanical and electronic components in the drive unit are therefore in the dry zone (inside its housing and inside the sealing unit (3)). The drive rod (610) is attached to the anchor unit (650). In Figures 22A, 22B, and 23, the electronics in the drive unit may have cable feed-through ports for electrical connection (630) of the cable to, for example, an external battery, battery, or other power source. . Examples of such electrical connections (630) can be seen in FIGS. 22A, 22B and 23. FIG. Note that the threads shown on the electrical connection (630) are optional or an alternative for securely connecting cables. The cable through port is typically at the top of the housing or the like, for example a Bal Seal connector such as the "Bal Conn Electrical Contact" or the "SYGNUS Implantable Contact System" or similar connections. It terminates with an electrical connection in the form of a system.

The access device (1) is, in some examples, a cardiac anchoring unit as part of an implantable medical device system. Cardiac anchoring units and principles of cardiac assist are described, for example, in WO2011/119101A1 of the same applicant, and related descriptions of that application, particularly FIG. is disclosed. This document is incorporated herein by reference in its entirety, and particularly with respect to FIG. 11c. The access device (1) provides a particularly advantageous implementation of such cardiac assist systems. The access device (1) may also be used in cardiac assist systems with other configurations disclosed in WO2011/119101A1.

As shown in FIG. 23, a further anchoring unit is provided in the heart and relative motion can be supplied by a drive unit, for example via rods (610). When implanted at the apex of the heart, the access device (1) may have a resting position, and a second anchor, such as the above-mentioned annuloplasty anchor, may be used as a heart pump. It may be moved in a push/pull motion synchronized with, for example, the heart's ECG, intracardiac pressure, cardiac output flow, etc., to assist in action and thus treat the patient.

11A, 11B, 11C illustrate the closed apical baseplate (1). The apical baseplate includes a connection interface (110) for mating engagement of a plurality of medical devices. A specific example is a hemostasis valve (2) and a drive unit (6) which may alternatively be attached to the same connection interface. And the plurality of medical devices each have a mating connection interface design for connection to the apical baseplate.

In some examples, the connection interface is placed on the proximal side of the apical baseplate (1) and the apical baseplate (1) is sealed on the distal side opposite its proximal side.

The connection interface (110) may include a locking unit (115) in some embodiments. The locking unit allows positive mating engagement when the apical baseplate (1) and multiple such medical devices are attached to each other. An example of a locking unit (115) is shown in FIG. 3A.

As shown in the apical baseplate examples of FIGS. 28A, 28B, 28C, 28D, 28E, the apical baseplate may include various connection interfaces (110) for mating with medical devices. . In one example, connection interface (110) may be a lip, eg, with a locking clip, eg, for mating engagement. In another example, the connection interface (110) may be, for example, a threaded hole for threading a screw, for example M2 size, any suitable size may be used. In yet another example, connection interface (110) can be a connection hole or connection loop for mating engagement by, for example, sutures, wires, threads, fibers, or the like. By way of example, Figure 28F illustrates an apical baseplate with two holders connected to one of the illustrated connection interfaces (110). Note that the apical baseplate may include one or more connection interfaces (110). In some examples, more than one different connection interface (110) may be applied.

FIG. 26 illustrates steps in an example method (700) for creating a transapical passageway in a beating heart.

A method or medical procedure includes determining a location (710) on an apical region for creation of a transapical passageway. This is done, for example, using imaging modalities that provide suitable image data for processing and analysis, eg, CT-based, MR-based, ultrasound-based image data. Alternatively or additionally, the position may be determined by tactile and/or visual inspection of the heart, for example during surgery.

The method further includes creating a transapical hole (720) at the determined apical region, such as by drilling and/or cutting through heart tissue.

The step of creating a transapical hole may conveniently be performed using an applicator tool (4) as described above and illustrated in Figures 12-19. Creating a transapical hole involves piercing the heart tissue at the apex with a penetrating needle (460) that houses the distal tip of tissue clipper (450) and passes through tube (410). may contain. Forward penetrating motion of the tissue clipper member and penetrating needle (460), here through the wall of the apex, is released by trigger (465) so that it is fired forward as one unit in one blow motion. may be The blow motion is rapid and reliable for drilling the initial perforation of heart tissue.

As the tissue clipper cuts through heart tissue, the rod member may be further advanced from the penetrating needle, and one or more retaining members extend radially outward from the distal end (472) of rod (470). may be extended by The retention member is then retracted for apposition against the heart wall inside the heart chamber at the puncture made by the puncture needle (460) (and it is appropriately retrieved into the puncture).

The sharpened edge (412) of the tube (410) is then pushed through the heart tissue toward the retaining member. Pushing the tube with respect to the rod member distal end (472) can be done in a safe and repeatable standardized manner by manipulation of the trigger (415) of the pistol grip (400). In addition, control dial (420) may be used by the operator to rotate the tube when cutting for improved cutting.

The expanded diameter of the retention member is preferably slightly smaller than the inner diameter of the lumen of tube (410), thereby retaining the tissue plug in the inner lumen of tube (410), as illustrated in FIG. 13D. You can completely pull yourself inside. The retaining member may also have a larger diameter. It may be juxtaposed with sharp edge (412) of tube (410). Thus, both retaining the tissue plug within the canal and covering sharp edges prevent potential unintentional cutting by the edges (412), increasing procedural safety for both patient and operator. increase In either case, embolism of the severed tissue plug from the apex is safely prevented.

When penetrating the heart tissue into the heart chambers, the interior of the heart may be indicated to the operator with a blood indicator on the applicator tool (4). For example, a blood indicator (490) may be provided at the distal end of the applicator tool tube in fluid communication with the proximal seal. The seal passes through the transparent portion and tube (410) to its proximal end through which blood passes from the heart chamber into the distal end and signals the penetration of cardiac tissue into the interior of the heart. It may include a tube lumen (410). The seal allows feedthrough without leakage of the penetrating needle and rod member therein.

Dilator (480) may be used to widen the tissue opening created by penetrating needle (460) and/or tube (410).

The method further includes delivering (730) an access device, such as an apical baseplate having a tubular through port to the transapical hole. Delivery may be by sliding the access device distally over tube (410) and/or dilator (480).

The method further includes attaching a flange unit of the access device to the outside of the heart. The flange unit may be attached around the transapical foramen by a suture technique called the "parachute technique." As a parachute procedure, both ends of a single suture (165) are sutured through the heart tissue around the hole to the appropriate distance to the hole. This may be done using a suitable template for many sutures around the hole. For example, 8-10 sutures around the flange (160) are sealed in a sealed manner when the channel within the tube (120) is properly closed, for example, with a hemostasis valve, sealing unit, plug, etc. That is, it may be sufficient to provide secure seating of the access device without bleeding from the heart chamber. Channels in tube (120) provide transapical working channels to and from the heart chambers in the beating heart.

Bleeding is prevented by retaining tube (410) in the hole. Two individual ends of the same suture are then passed through the flange unit and held away from the heart surface on the outside of the tube (410) of the tool (4). The suturing pattern is repeated using additional suture material to provide several suture "pairs" spaced around the hole and tube (410). The access device (1) is then lowered or parachuted down against the outer heart wall and the plate (100) and flange (160) abut the heart surface and the access device (1) 1) is advanced until the opening of the tube (120) is inside the heart chamber. After all suture pairs have been secured, for example by appropriate knots, the result is a blood-tight flange with a tubular port (120) at the transapical foramen.

The method may further comprise removably connecting the hemostasis valve unit (2) to the access device (1). The hemostasis valve unit (2) may be pre-attached to the tube (410) and placed in the access device (1) by sliding along the tube (410). Alternatively, the hemostasis valve unit (2) may be pre-attached and releasably attached to the access device (1) by sliding along a tube to an apical puncture as described above. , may be placed in the transapical passageway.

The applicator tool tube (410) may then be withdrawn. As shown in FIG. 6, it is withdrawn from the access device and valves that remain intact in the heart.

Medical procedures and/or delivery of medical devices may occur through the ports of valve (2) and port (120). The method may include, for example, passing a drive rod (610) of a cardiac assist system transapically through the hemostasis valve (2) and the access device (1) and into the heart.

Delivering the medical device to the heart chamber may include placing an annuloplasty chain ring in the heart valve annulus. A delivery catheter of the delivery system may be introduced through an access device (1) having an affixed valve (2) for this purpose. The delivery catheter may then be removed from the patient. Blood leakage from the heart is continuously prevented by the hemostasis valve unit (2).

A sealing device is slid over the drive rod (610) through the valve (2) and affixed to the access device (1), allowing the sealing access device (1) to separate the wet/dry zones. to The proximal end of drive rod (610) is then connected to drive unit (6) during attachment of drive unit (6) to access device (1).

When the sealing device (3) is introduced into the access device (1) sealing the transapical passageway, for example through the hemostasis valve unit (2) as described above for creating a wet/dry zone separation. There is A rod-like element may pass across the through port of the sealing element (3). Alternatively, the distal end port of the sealing unit (3) may be provided as an occlusive element such as a membrane or hub. A magnetic connection (340) to an element in the heart chamber may be established by the units shown in Figures 24A, 24B and 24C.

The valve (2) may then be removed as well as medical devices affixed to the access device prior to completing the surgery. The method (700) decouples the hemostatic valve unit from the apical baseplate and removes the hemostatic valve unit from the apical baseplate by pulling the hemostatic valve unit away from the patient or splitting or isolating the hemostatic valve unit. It may include a process.

Additionally, examples of the present disclosure may include one or more sensors. For example, an access device (1), a hemostasis valve (2), a sealing unit (3), a cardiac assist drive device (6), a transapical access system (5), or any other device attachable to the access device (1). A medical device (not shown) may include such sensor(s) implanted within a patient's body.

Since measurements are often made in the blood (wet zone) and sensors often contain electrical components that need to be separated from the blood in a dry zone, sensors are often separated into wet and dry zones. must belong to both Therefore, it is important to have a feedthrough port (320) to facilitate this separation of wet and dry zones of the sensor.

Accordingly, some examples of this disclosure further include one or more optional sensors (620).

Such sensors may pass through the feedthrough port (320) of the bellows (310) instead of the drive rod (610) as previously described. In another alternative/example, two or more (multiple) feedthrough ports (320) are present such that multiple sensors and/or drive rods (610) can pass through different feedthrough ports (320) simultaneously. obtain. The feedthrough port (320) need not be part of the bellows (310) as previously described, but instead may be a separate part/unit of the sealing unit (3). An example of a multiple feedthrough port or multi-lumen port (320) preferably includes separate channels for sensors such as, for example, pressure sensors (not shown).

In one example, sensor (620) may include one or more pressure sensors, such as those connectable to a port having a distal end within the heart chamber. This may provide intracardiac pressure, such as in the left and right ventricles of the heart. Pressure data not only provides important clinical data, but may also be used in control algorithms for implantable medical devices. Other relevant clinical parameters, such as the patient's heart rate and/or various cardiac arrhythmias may also be extracted from the pressure data.

In one example, sensor (620) may additionally or alternatively include one or more ECG electrodes connectable to a port having a distal end within the heart, for example. This would provide the intracardiac electrical activity of the heart. ECG data not only provides important clinical data, but may also be used in control algorithms for implanted medical devices. Other suitable clinical parameters may also be extracted from the ECG data, such as the patient's heart rate and/or various cardiac arrhythmias.

In one example, sensor (620) additionally or alternatively includes one or more optical and/or electrical sensors used to obtain blood flow and/or blood volume measurements in the heart. It's okay. Such sensors may be placed, for example, in optical ports and/or windows (not shown) facing the wet zone of the heart. This makes it possible, for example, to obtain measurement data of intracardiac blood volume in the left ventricle of the heart. Blood flow/blood volume data not only provides important clinical data, but may also be utilized in control algorithms for implantable medical devices. Other relevant clinical parameters, such as the patient's heart rate and/or stroke volume and/or cardiac output and/or SpO2 may also be extracted from the blood flow/blood volume data.

In one example, sensor (620) is additionally or alternatively connectable to one or more motion sensors, e.g., a port having a distal end within the heart and/or to drive rod (610). may include connected This will provide measurement data and/or activity data about the intracardiac motion of the heart. Motion data may represent, for example, motion up and down the mitral valve and/or the atrial/ventricular plane. This operational data not only provides important clinical diagnostic data, but may also be utilized in control algorithms for implantable medical devices. Other relevant clinical parameters, such as the patient's heart rate and/or various cardiac arrhythmias, can also be extracted from the motion data. Examples of motion sensors include magnetic, such as Hall effect sensors, and/or optical. Examples of motion sensors may also include one or more accelerometers.

Measurement data obtained from the sensor(s) (620) may be used, for example, to control a medical device, for example implemented in the hardware and/or software of a medical device such as a cardiac assist system. may be part of the control algorithm. Data from sensors may be used, for example, to monitor important physiological properties and/or sensor data is used to extract and/or calculate important clinical parameters that need to be monitored. sometimes. In addition to monitoring physiological characteristics and clinical parameters, they may also be part of a surveillance system. The acquisition and management of patient data is not only important for patient safety, medical device functionality, etc., but also because regulatory requirements for medical devices mandate the collection, retention and analysis of post-market clinical data. is important in that sense.

Such measurement data can be provided by sensors (620) implanted in the device examples described herein, but has heretofore been difficult to provide.

FIG. 27 illustrates the steps of an example of a method (800) for transapically implanting a cardiac assist system. A method (800) or medical procedure includes attaching (810) a cardiac assist unit (6) to an access device (1) that includes a sealed apical baseplate (100). The apical baseplate (100) includes a sealed tubular through port positioned through the heart tissue to the ventricle. The flange unit is attached to the baseplate (100) and the heart (10). The access device (1) is attached to itself with a sealing unit (3). The method may include inserting a delivery tube through a hemostasis valve attached to the access device prior to sealing the access device to provide a wet/dry zone as described above.

Below are some additional examples of the present disclosure.

Example 31. An applicator tool (4) for forming a transapical passage in a beating heart, said applicator tool (4) comprising:
a tissue clipper (450) insertable through a tube (410) and having a distal tip configured to penetrate cardiac tissue to the apex of the heart; and
said tube (410) having a sharpened edge at its distal end and configured to cut cardiac tissue up to said apex to a transapical foramen in said heart; and said cardiac tissue of said tissue clipper. said tissue clipper having an expandable flange for preventing retraction through, wherein said flange is configured to retain said cut heart tissue within said tube (410). be done.

Example 32. 32. The applicator tool of example 31, wherein the distal end of the tube is in fluid communication with a proximal seal containing a blood indicator (490).

Example 33. 33. The applicator tool of embodiment 31 or 32, wherein the distal end of the tube (410) is configured to appose the heart tissue at the apex.

Example 34. Example 31- comprising an access device (1) for the heart having a tubular through-port (120) adapted to be placed over the heart tissue when advanced over the tube (410) 34. The applicator tool of any one of 33.

Example 35. 35. The applicator tool of example 34, wherein a removable hemostasis valve unit (2) is attachable to said access device (1) and slidable over said tube (410).

Example 36. a dilator having a diameter greater than the transapical foramen in use made in the heart by the tube (410), so as to widen the transapical foramen when the dilator is inserted therein. 36. The applicator tool of any one of embodiments 31-35, comprising in combination a dilator, wherein the applicator tool is configured

Example 37. An applicator tool (4) for creating a transapical passage in a beating heart, said applicator tool (4) comprising:
a penetrating needle (460) insertable through a coaxial dilator (480) having a distal tip configured to provide an opening through heart tissue at the apex; and
said dilator (480) for widening said opening in said heart tissue; and a tubular through-port (120) adapted to be positioned across said heart tissue when advanced over said dilator (480). ), and/or wherein said distal end of said penetrating needle is in fluid communication with a proximal seal containing a blood indicator ( 1), an applicator tool (4).

Example 38. 38. The applicator tool of example 37, wherein a removable hemostasis valve unit (2) is attachable to said access device (1) and slidable on said dilator (480).

Example 39. A transapical access system for creating a transapical passageway in a beating heart, said system comprising an access device for the heart according to any one of originally filed claims 1-21 (1 ) and/or
39. An applicator tool (4) according to any one of embodiments 31-38, for creating a transapical passageway and delivering said access device (1) to the apex of said heart.

Example 40. 40. The system of example 39, comprising a fixture template (190) for targeted perforation of the apex of the heart.

Implementation 41. 41. The system of example 40, wherein the fixture (190) has a patient-specific shape, such as selected from a plurality of fixtures or manufactured based on image data of the apex.

Example 42. A method of creating a transapical passageway in a beating heart, the method comprising: creating a transapical passageway through myocardial tissue to create a transapical foramen in the determined apical region; determining a position, delivering an access device having a through-port to the transapical hole, attaching a flange unit of the access device to the heart, and removably connecting a hemostasis valve unit to the access device. A method comprising steps.

Example 43. 43. The method of example 42, comprising placing multiple sutures in the transapical foramen for attaching the flange unit of the access device to the heart.

Example 44. 44. The method of example 42 or 43, comprising cutting the heart tissue with a sharpened edge at the distal end of the tube at the apex.

Example 45. 45. The method of any one of Examples 42-44, comprising expanding a flange of the tissue clipper to prevent withdrawal of the tissue clipper through the heart tissue.

Example 46. 42, or 43. The method according to 43.

Example 47. 47. A method according to example 45 or 46, comprising retaining the severed heart tissue within the tube by the expanded flange of the tissue clipper member.

Example 48. Example 42 including indicating penetration of the heart tissue into the heart by a blood indicator at a distal end of a tube of an applicator tool in fluid communication with a proximal seal containing a blood indicator 47. The method of any one of .

Example 49. creating with the transapical passage applicator tool piercing heart tissue at the apex with a penetrating needle of the applicator tool insertable through a coaxial dilator having a distal tip that dilates the heart tissue. 44. The method of example 42 or 43, comprising the step of:

Example 50. 50. The method of example 49, comprising positioning a tubular through-port of the access device over the heart tissue when advanced over the dilator.

Example 51. 51. The method of example 50, comprising removably attaching a removable hemostasis valve unit to the access device and sliding the removable hemostasis valve unit over the dilator.

Example 52. passing a drive rod of a cardiac assist unit transapically through the hemostasis valve and into the heart;
attaching a sealing unit to the access device through the hemostasis valve unit and beyond the drive rod;
sealing the transapical passageway through the access device with the sealing unit;
52. The method of Examples 42-51, comprising removing said hemostasis valve unit from said access device.

Example 53. disconnecting the hemostasis valve unit from the access device; removing the hemostasis valve unit out of the patient; or removing the hemostasis valve unit from the access device by dividing or partitioning the hemostasis valve unit. The method described in Example 52.

Example 54. 54. The method of any one of Examples 42-53, comprising placing an annuloplasty chain ring in a heart valve annulus. .

Example 55. 55. The method of any one of Examples 42-54, comprising removing a delivery tube from the patient and sealing against blood leakage from the heart with a hemostasis valve unit.

Example 56. The applicator tool is an applicator tool according to any one of embodiments 22-29, and the access device is an access device according to any one of originally filed claims 1-21. and/or the hemostasis valve is a hemostasis valve according to any one of claims 22-26.

Example 57. A method of transapically implanting a medical device on a beating heart, comprising said medical device removably attached to a sealed access device (1) affixed to said heart.

Example 58. The access device includes a sealed tubular through port adapted to be placed in a heart chamber over heart tissue;
58. The method of embodiment 57, comprising a flange unit sealingly securing the access device to the heart.

Example 59. 59. The method of example 57 or 58, comprising attaching a sealing unit to the access device to form a wet zone and dry zone separation in a mammalian body.

Example 60. 60. The method of any one of Examples 57-59, comprising inserting a delivery tube through a hemostasis valve attached to the access device.

Example 61. attaching the medical device to the sealed access device while the hemostasis valve and the sealing unit are attached to the access device; The method of any one of Examples 57-60, comprising disconnecting the valve.

Example 62. 62. The method of any one of examples 57-61, wherein the medical device is removably attached to the sealed access device.

Example 63. 63. The method of any one of examples 57-62, wherein the medical device is included in a cardiac assist system.

64. An embodiment, wherein the access device is the access device according to any one of claims 1-21 and/or the hemostasis valve is the hemostasis valve according to any one of claims 21-26 64. The method of any one of 57-63.

A method for accessing a patient's heart comprising:
accessing the heart of the patient;
accessing a chamber of the heart;
securing a baseplate to the apical region of the heart and extending it into the heart chamber;
A method comprising: tying a sealing unit to the baseplate, thereby creating a dry zone isolated from the heart chamber.

Those skilled in the art will appreciate that portions of the devices disclosed herein can be provided in combination with other devices and as stand-alone devices independent of other devices or combined systems and methods described herein. , may be implemented. One example is the access device (1), which can be provided as an access port into the heart for applications other than those described herein. Another example is an application tool (4) that may be provided to safely pierce the tissue wall and provide a tissue passageway in the tissue wall. A removable hemostasis valve (2) may also be provided for attachment to units other than the access device (1).

Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Terms as defined in commonly used dictionaries are to be construed as having a meaning consistent with their meaning in the context of the relevant technical field, and are not idealized unless explicitly defined herein. It will be further understood that it will not be construed in a simplistic or overly formal notion.

The invention has been described with reference to specific embodiments. However, other embodiments than those described above are equally possible within the scope of the invention and are limited only by the appended claims. List of Cited 1 Access Devices for Cardiac (1) Access Device for Cardiac (100) Apical Baseplate (110) Connection Interface (115) Locking Unit (120) Tubular Penetrating Port (125) Sealing Unit (3) sealing surface (130) for hemostatic valve (2) sealing surface (150, 151) for hemostasis valve (2) mounting spike (155) bayonet joint (160) flange unit (165) suture (170) suture hole (190) Template (191) for placement of access device (192) Template indentation (192) Indentation (200) for suture to sew two hemostasis valve units (inflatable valve assemblies) together Housing (202, 204) ) divisible housing parts (210) inflation port (220) inflatable balloon member (222) balloon lobes (225) valve through port (230) sealing surface (250) for sealing to the access device (1) , 251) Mounting opening (fitted with (150, 151))
(255) bayonet pin (260) for joint (155) sealing unit (3) sealing element (bellows assembly)
(310) bellows (320) feedthrough port (325) first sealing member (326) for sealing against access device second sealing member (330) for sealing feedthrough port detention unit ( 340) Magnetic Coupling (4) Applicator Tool for Creating Transapical Passage (Apical Drilling Assembly)
(400) Pistol grip (410) Tube (412) Sharp tip of tube (415) Trigger (417) to push tube (410) forward Claw (420) Control dial (450) to rotate tube Tissue Clipper (455) Tissue Clipper (450)/Proximal End (460) of Rod (470) Penetrating Needle (461) Seat (465) Needle Trigger (466) Needle Spring (467) Safety Pin (470) Rod (460) 471) Shoulder (472) Tip of rod with holding unit (distal part)
(473) Retaining unit, e.g., barb, hook, fluke, wire mesh, etc. (474) Movable and lockable restraining element (475) Tissue plug (480) Dilator (490) Penetration/blood indicator (5) Transapical Access System (6) Drive Unit for Cardiac Assist (610) Drive Rod (620) Sensor (630) Electrical Connections (650) Anchor Unit/Annuloplasty Implant (7) Delivery System (70) Delivery Tube (72) Insertion unit (74) Pusher (700) Methods of creating a transapical passageway on a beating heart (710-730) Method steps (800) Method of transapically implanting a cardiac assist system (810) Method steps (10) ) heart (12) apical region (14) of heart (10) exterior of heart (15) interior of heart (20) chamber (30) wet zone (32) dry zone

Claims (52)

An access device (1) for a heart chamber comprising a permanently implantable apical baseplate (100) and a sealing unit (3), not contained in a hemostasis valve and within a patient's body. and simultaneously providing separation of a wet zone in a heart chamber from a dry zone having a gaseous environment. The access device of claim 1. The access device (1) includes the apical baseplate (100) having tubular through-ports (120) adapted to be placed over cardiac tissue, the access device (1) having a removable hemostatic valve unit (2) inserted into the apical baseplate (100). 100), having a first open patient configuration and optionally including a feedthrough port (320) removably attached to the proximal side of the sealing unit (3) is preferred has a second closed patient configuration attached distally to the baseplate (100) to provide the separation of zones. The sealing unit (3) is deliverable through the hemostasis valve (2) for attachment to the apical baseplate (100), wherein the second configuration is the first configuration. 3. The access device of claim 2, alternatively or wherein said second configuration is added to said first configuration only during transition to a second configuration. 3. The sealing unit (3) is configured to be delivered through the hemostasis valve unit (2) for the transition from the first configuration to the second configuration or 4. The access device according to 3. 5. The apical baseplate (100) of any one of claims 1 to 4, wherein the apical baseplate (100) includes a flange unit (160) for sealingly attaching the baseplate (100) to the heart having the chambers. access device. said flange unit (160) is attachable to the outside of said heart tissue by attachment elements, said attachment elements preferably being sutures (165), hooks, clips, staples and/or screws; 6. The access device of claim 5. 7. The access device of claim 5 or 6, wherein the flange unit (160) includes a small ring for receiving sutures (165) for attaching the flange unit (160) to the heart. 8. The removable hemostasis valve (2) is preferably connectable to the through-port (120) on the proximal side of the apical baseplate (100). access device. The access device of any one of claims 2-8, wherein the removable hemostasis valve (2) is a balloon pressure controllable balloon valve. The removable hemostasis valve (2) according to any one of claims 2 to 9, having a longitudinally splittable housing (200) consisting of at least two releasably attachable housing parts. access device. The removable hemostasis valve (2) is configured in the first configuration for delivering a medical device to and from the heart interior (15) and the second configuration. a through port (225) providing a communication channel for delivering said sealing unit (3) for said transition to a configuration of or for subsequent replacement of said sealing unit (3); An access device according to any one of claims 2-10. comprising a drive unit (6) connected to the baseplate (100) in the second configuration, wherein the hemostasis valve (2) is connected to the apical baseplate (100). 12. The access device of any one of claims 1-11, configured to be detached from the apical baseplate (100) at any time. A compact as claimed in any one of claims 2 to 12. Said sealing unit (3) comprises at least one sealing member such as a bellows (310) and preferably a first sealing member (325) arranged for sealing against said tubular through-port (120). The access device of any one of claims 2-12, comprising one membrane. 14. The access device of claim 13, including the bellows attached to the apical baseplate to extend distally from the apical baseplate. 15. The access device of claim 13 or 14, comprising a plurality of membranes or bellows in a membrane-in-membrane or bellows-in-bellows arrangement. 10. The access device of claim 9. 16. The access device of claim 15, wherein the different bellows comprise different materials with different material properties for bellows in a bellows solution. 15. The access device of claim 13 or 14, wherein various bellows are made of the same material. The access device of any one of claims 13-17, wherein at least one said membrane or said bellows is made of an elastic material. 19. The sealing unit (3) of any of claims 2-18, wherein said sealing unit (3) comprises said feedthrough port (320) and optionally comprises a second sealing member (326) at said feedthrough port (320). An access device according to any one of the preceding claims. The access device according to any one of claims 1 to 19, wherein said sealing unit (3) comprises a detention unit (330) for providing detention of blood and/or gases. 21. Any one of claims 1 to 20, comprising a cardiac assist unit having a drive rod (610) arranged to pass transapically through the sealing unit (3) and into the heart. access device as described in Section 1. A removable and/or reattachable hemostasis valve unit (2), said hemostasis valve unit (2) having a longitudinally divisible housing (200), said housing (200) comprising , a distal end and a proximal end, and at said distal end an apical baseplate (100) of an access device (1) for the heart, such as the one according to any one of claims 1-21. ) and comprises a pneumatic valve in a through port (225) of said valve unit (2) between said distal end and said proximal end. 23. The hemostasis valve of claim 22, wherein said pneumatic valve comprises an inflatable balloon member or tubing coil for controlling an internal flow path within said through port (225) of said hemostasis valve unit (2). unit. said housing (200) having a proximal end with an opening to said through-port (225) of said valve unit (2) for receiving a medical device passing through said through-port (225); A hemostatic valve unit according to claim 22 or 23. Said housing (200) is longitudinally splittable for radially removing and optionally reattaching said valve unit to said apical baseplate (100). The hemostasis valve unit according to any one of claims 22-24, wherein A hemostasis valve unit according to any one of claims 22 to 25, comprising a reservoir unit for maintaining a substantially constant pressure in said pneumatic valve. A medical system comprising a cardiac assist unit configured to be implanted transapically, wherein said cardiac assist unit is attachable to a sealed access device (1), preferably A medical system attachable to the access device (1) according to any one of claims 1-21. A sealed access device (1), preferably an access device (1) according to any one of claims 1 to 21, which is mated with a plurality of medical devices having a mating connection interface. A sealed access device (1) comprising a connection interface (110) configured to matingly engage. 29. The connection interface (110) is on the proximal side of the access device (1) and the access device (1) is sealed on the distal side opposite to the proximal side. The sealed access device according to . Said connection interface (110) comprises a rotatable connection of said medical device to said access device (1), wherein said rotatable connection is about a pivot point of said connection interface (110). 30. The sealed access device of claim 28 or 29, optionally including movement in three dimensions. A system for accessing a patient's heart, comprising an apical baseplate, mating with the apical baseplate, for permanent placement in an apical region of the heart and for providing access to a chamber of the heart. a sealable unit, the chamber defined by a wet zone, a dry zone created by fitting the seal unit to an apical base unit, the dry zone being separated from the wet zone; A system comprising said dry zone, a zone defined by a gaseous environment and positioned within said patient during use of said system. 32. The system of claim 19, further comprising an image processing system and a processor, and further comprising a hemostasis valve mateable with the apical baseplate. a first configuration in which only the hemostasis valve is mated with the apical base; a second configuration in which only the sealing unit is mated with the apical base; 33. The system of claim 32, further comprising a third configuration, both fitted to the apical base. 8. The system of claim 7. 34. The system of claim 33, wherein the third configuration is configured by placing the sealing unit inside the hemostasis valve. 32. The system of claim 31, further comprising a flange unit attached to the apical baseplate and attachable to the heart. 36. The system of claim 35, wherein the flange unit includes tissue attachment elements. 37. The system of claim 36, wherein the tissue attachment element includes a ringlet for receiving suture material. 33. The system of claim 32, wherein the apical baseplate includes a through port, wherein the hemostasis valve is matable with the apical baseplate to the through port. 33. The system of claim 32, wherein the hemostasis valve comprises a balloon valve having a balloon and a mechanism for controlling balloon pressure. 33. The system of claim 32, wherein the hemostasis valve includes a longitudinally divisible housing. 33. The system of claim 32, wherein the hemostasis valve includes a through port communication channel extending from a proximal end of the hemostasis valve to the interior of the heart. 42. The system of any one of claims 31-41, further comprising a drive unit mateable with the apical baseplate. 4. The sealing unit includes a bellows section and a first sealing member, the first sealing member dimensioned to sealingly mate with the apical base through-port. 31. The system according to 31. 32. The system of claim 31, wherein said sealing unit includes a feedthrough port. The system of any one of claims 31-44, further comprising a cardiac assist unit. 46. The system of claim 45, wherein the cardiac assist unit includes a drive rod dimensioned to pass transapically through the sealing unit. 47. The system of any one of claims 31-46, further comprising a plug insertable into the apical baseplate to close the apical baseplate. 47. The system of claim 45 or 46, wherein the cardiac assist unit is detachably connected to the apical baseplate. 49. The system of any one of claims 31-48, further comprising a connection interface associated with the apical baseplate, the connection interface configured to engage a plurality of medical devices. 50. The system of claim 49, wherein the connection interface is located proximally of the system and the system further comprises a sealant located distally of the system. 51. The system of claim 49 or 50, wherein the connection interface includes a connection portion that is rotatable with respect to the apical baseplate. A device for providing access to a patient's heart, the baseplate being dimensioned for attachment to the heart and dimensioned to extend from the exterior of the heart to a chamber of the heart. a sealing unit connectable to the baseplate to create a barrier between the chambers of the heart and the external environment; and the external environment within the patient. ,device.

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